Propranolol 10mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Propranolol hydrochloride

Διαθέσιμο από:

A A H Pharmaceuticals Ltd

Φαρμακολογική κατηγορία (ATC):

C07AA05

INN (Διεθνής Όνομα):

Propranolol hydrochloride

Δοσολογία:

10mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 02040000; GTIN: 5025903001843 5025903092766

Φύλλο οδηγιών χρήσης

Propranolol 10mg Tablets BP
Module 1
1.3 Product Information
1.3.1
S
UMMARY OF PRODUCT CHARACTERISTICS
, LABELS AND LEAFLETS
P
ACKAGE
L
EAFLET
:
I
NFORMATION FOR THE USER
PROPRANOLOL 10MG TABLETS BP
(Propranolol Hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Propranolol Tablets are and what they are used for
2.
What you need to know before you take Propranolol Tablets
3.
How to take Propranolol Tablets
4.
Possible side effects
5.
How to store Propranolol Tablets
6.
Contents of the pack and other information
1.
WHAT PROPRANOLOL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is propranolol 10mg tablets BP. The active
ingredient is
propranolol. Propranolol tablets is produced as film-coated tablets in
one strength. Each
tablet contains 10 mg of propranolol hydrochloride.
Propranolol is one of a group of drugs called beta blockers. It has
effects on the heart and
circulation and on other parts of the body.
Propranolol can be used for many conditions including:
•
hypertension (high blood pressure),
•
angina (chest pains),
•
some arrhythmias (disorders of heart rhythm),
Propranolol 10mg Tablets BP
Module 1
1.3 Product Information
•
protection of the heart after a myocardial infarction (heart attack),
•
prevention of migraine,
•
essential tremor, anxiety,
•
certain thyroid conditions (such as thyrotoxicosis, which is caused by
an overactive
thyroid gland),
•
hypertrophic cardiomyopathy (thickened heart muscle),
•
phaeochromocytoma (high bloo

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Propranolol 10mg Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of propranolol hydrochloride.
Excipient(s) with known effect:
•
Lactose- 89.0mg of lactose per tablet.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film coated tablets
The tablets are pink, film-coated biconvex tablets embossed ‘10’
on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
The control of hypertension.
•
The management of angina pectoris.
•
Long term management against re-infraction after recovery from acute
myocardial infraction
•
The control of most forms of cardiac dysrhythmias.
•
The prophylaxis of migraine.
•
The management of essential tremor.
•
The
relief
of
situational
anxiety
and
generalised
anxiety
symptoms,
particularly those of somatic type.
•
Prophylaxis of upper gastro-intestinal bleeding in patients with
portal
hypertension and oesophageal varices.
•
The adjunctive management of thyrotoxicosis and thyrotoxic crisis.
•
Management of hypertrophic obstructive cardiomyopathy.
•
Management of phaeochromocytoma peri-operatively (with alpha blocker).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tablets are to be taken orally with a drink of water.
The lowest possible dose should be used initially in all patient
groups,
but
this
is
particularly
important
in
elderly
patients.
Subsequent
increases in dose should be gradual.
POSOLOGY:
ADULTS:
Hypertension:
A starting dose of 80mg twice a day may be increased at weekly
intervals
according to response. The usual dose range is 160-320mg per day. With
concurrent diuretic or other antihypertensive drugs a further
reduction of
blood pressure obtained.
Angina, Migraine and Essential Tremor:
Initially, 40mg two or three times daily, increased by the same amount
at
weekly intervals according to patient response. An adequate response
in
migraine and essential tremor is usually seen in the range
80-160mg/day
and in angina in the range 120-